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Page 1: User Manual - Saalmann medical

User manual Saalux® UV comb page 1

User Manual

Page 2: User Manual - Saalmann medical

User manual Saalux® UV comb page 2

Page 3: User Manual - Saalmann medical

User manual Saalux® UV comb page 1

User manual

Saalux® UV comb

Version UV-B Narrow band (311 nm), orange cap

UV-A1 (370 nm max.), grey cap

EU (230V/50Hz) ☐ No. 07-02-000-01 ☐ No. 07-02-000-02

UK (240V/50Hz) ☐ No. 07-02-000-03 ☐ No. 07-02-000-04

JP1 (100V/50Hz) ☐ No. 07-02-000-06 ☐ No. 07-02-000-07

JP2 (100V/60Hz) ☐ No. 07-02-000-08 ☐ No. 07-02-000-09

US (120V/60Hz) ☐ No. 07-02-000-10 ☐ No. 07-02-000-11

Page 4: User Manual - Saalmann medical

User manual Saalux® UV comb page 2

Dear customer, we are delighted that you decided to purchase a Saalmann®

therapy device. You made an excellent choice as the Saalux® UV comb sets new

standards in terms of usability and design. The one-piece comb attachment

comprises a disc filter which is integrated into the hair parter and protects the UV

lamp from soiling. Moreover, the detachable comb attachment facilitates easy

cleaning by rinsing and flushing out scales or hairs which usually soil the UV

comb in the course of treatment.

The following directions for use familiarise you with the therapy device.

Please review them carefully!

Page 5: User Manual - Saalmann medical

User manual Saalux® UV comb page 3

Content

1 Scope of Delivery 4

2 Accessories and Spare Parts 4

3 Safety Information 4

4 Key to symbols 7

5 Intended Use 8

6 Basic Information on UV Phototherapy 8

7 Indications 9

8 Contraindications 9

9 Initial Operating Instructions 9

10 Therapy Recommendation 10

11 Cleaning and Disinfection 17

12 Transport and Storage 17

13 Errors and Troubleshooting 18

14 Life cycle and service life 18

15 Maintenance and Repair 18

16 Warranty 18

17 Electromagnetic compatibility 19

18 Spectral Distribution of the Flow of Radiation 19

19 Technical Data 19

20 Disposal instructions 20

21 Manufacturer contact information 20

Appendix 1 – Electromagnetic compatibility 21

Appendix 2 – Patient diary 23

Page 6: User Manual - Saalmann medical

User manual Saalux® UV comb page 4

1 Scope of Delivery

The set consists of the therapy device with UV lamp and comb attachment, UV

protective goggles, count-down timer and a user manual.

2 Accessories and Spare Parts

Comb attachment Item No. 07-02-005-01

User manual UK Item No. 07-02-001-02

UV-protective goggles, red Item No. 07-02-002-01

Count down timer Item No. 07-02-003-01

3 Safety Information

„Caution“ safety information : this sign precedes important notices in

the user manual.

The therapy device may only be used for the indications specified in

this user manual.

The therapy device may only be used for the „intended use“

specified in this user manual. Any use beyond the defined scope is

considered „not as intended“ and will immediately render the

warranty void. The manufacturer accepts no responsibility for

personal injury or damage to property resulting from „not as

intended“ use.

The therapy device may only be used when in proper condition and

with the original accessories.

The therapy device may only be operated in dry rooms and in the

temperature range stated in this user manual.

Water and electricity are a dangerous combination! To avoid risk of

electrocution:

– do not use this equipment in wet surroundings (e.g. in the

bathroom or near a shower or swimming pool),

– do not let water run into the appliance.

The use of this device next to other equipment should be avoided,

as it may result in improper operation. If use in the manner

described above should nevertheless be necessary, this equipment

and the other equipment should be checked for proper operation.

Page 7: User Manual - Saalmann medical

User manual Saalux® UV comb page 5

This device emits UV radiation through the transparent comb

attachment, which can cause eye or skin irritation. Avoid the UV

radiation of eyes and healthy skin. The UV radiation is not visible for

the human eye and can lead to corneal inflammation (photokeratitis)

and eye inflammation (photoconjunctivitis) within a short time.

It is imperative that during a therapy session, you wear the UV

protective goggles included in the scope of delivery. Simply closing

your eyes without protective goggles during a therapy session does

not offer sufficient eye protection. Also, avoid looking into the UV

lamp with unprotected eyes; immediately switch off the therapy

device after treatment and also during short-term interruptions in the

treatment session.

Never operate the device without comb attachment.

UV-radiation can cause the skin to get sun burnt within a short time.

It is imperative that you pay attention to the therapy

recommendations specified in the user manual.

To avoid erythema (sun burn), healthy skin (e.g. ears) must be

protected with a high protection factor sun cream, which is to be

applied to those areas in due time before the treatment session (see

page 8)

The intensive use of the therapy device over years can promote the

development of skin cancer. Avoid excessive sun exposure during

the treatment cycle; also, adjust your leisure behaviour during this

time. You should not visit tanning studios while using the device in a

treatment cycle.

This device is not intended for use by persons with reduced

physical, sensory or mental capabilities, or lack of experience and

knowledge, unless they have been given supervision or instruction

concerning use of the equipment to avoid the risk of fire or burns.

This device is not intended for independent use by children. The

treatment of children is carried out exclusively by adults. Children

should be supervised to ensure that they do not play with the

equipment to avoid the risk of fire and burns.

Page 8: User Manual - Saalmann medical

User manual Saalux® UV comb page 6

Do not leave the device unattended when it is switched on to avoid

the risk of fire or burns.

The device may not be altered.

Check if the voltage indicated on the device corresponds to the local

mains voltage before you connect the equipment to avoid risk of

electrocution or permanent damage to the device.

Make sure that you can unplug the power cord from the wall outlet

at any time.

Always unplug the device after use and in case of a power failure to

avoid risk of damage to the equipment.

Protect the device against unauthorized use:

- unplug the AC adapter from the socket immediately after use,

- store the device securely so that unauthorized persons cannot

access the device (e.g. by locking it away).

Do not use it near children and never leave the device unattended

(Danger of UV exposure and strangulation).

Do not subject the equipment to heavy shocks to avoid risk of

damage to the lamp.

RF communications equipment (radios) and their accessories

should not be used within 30 cm of the components and cables of

the Saalux UV Comb. Observe the recommended EMC protective

distances in Appendix 1. Failure to do so may lead to a reduction in

the performance of the device.

Page 9: User Manual - Saalmann medical

User manual Saalux® UV comb page 7

4 Key to symbols

Symbols in the user manual and on the unit:

Caution: Important note!

Medical Device

Caution: Ultraviolet radiation!

Manufacturer‘s CE-declaration with no. of Notified Body

Do not stare at light source!

Manufacturer

Wear UV protective goggles!

Item No.

Read the user manual!

Batch Code

Type BF applied part

Class II equipment

Keep dry!

Disposal instructions: Do not dispose of the equipment with domestic waste!

Page 10: User Manual - Saalmann medical

User manual Saalux® UV comb page 8

5 Intended Use

The unit is intended to be used in closed rooms. Allow the unit to reach room

temperature before conducting a treatment. The device may only be used in a dry

environment. The required minimum distance to shortwave microwave devices

depends on their frequency and transmission power and is defined in the EMC

tables (see attachment 1). For additional information, please refer to item 9 in the

operating instructions.

At the start of the therapy, approx. 3 - 5 treatments per week are to be conducted.

Exposure time depends on the patient’s individual sensibility and skin type.

Special care has to be taken never to reach the erythema threshold (development

of sun burn). We refer to the specific instructions in this user manual. Due to the

intermittent appearance of clinical symptoms, an according maintenance therapy

in a domestic setting is indicated.

The treatment is conducted based on a doctor’s recommendation and in

accordance with the treatment guidelines laid down in the user manual. Any other

use going beyond or deviating from the defined scope of usage is considered

„improper use” and may lead to health impairment and injury.

6 Basic Information on UV Phototherapy

UV phototherapy is an

established procedure,

recognized for decades for the

treatment of various skin

diseases, particularly

psoriasis, neurodermatitis and

vitiligo. UV radiation affects

the upper skin cells and, after

repeated application, positively

influences the immune system

and the skin‘s regeneration behavior. Depending on the clinical picture, selected

UV-spectral ranges (UV-B and UV-A) are applied, which in low strength are also

present in natural sunlight.

Page 11: User Manual - Saalmann medical

User manual Saalux® UV comb page 9

7 Indications

According to version (UV-B narrowband, UV-A1) and recommendation by a

medical professional, the Saalux® UV comb is used for the following indications:

Psoriasis

Vitiligo

Neurodermatitis

8 Contraindications

The UV therapy must not applied in case of:

Tumorous skin changes

Abnormal sensitivity of the skin to light, e.g. Xeroderma

Pigmentosum

Porphyria disorders

Florid Tuberculosis or other active processes

Hyperthyroidism

Lupus Erythematosus

Accompanying medicinal treatment with potential skin

damage

Increased sensitivity to light

Following side effects may occur:

Erythema (sunburn)

Dry skin

9 Initial Operating Instructions

The device may only be used with a power supply that matches the supply

voltage specified on the rating plate. To ensure safe operation of the unit, all its

cables, plugs, control elements, and housing components must be in faultless

condition. Prior to each use, check the device for possible damage; a defective

unit may not be operated. Pay attention to the references on the unit and in the

user manual. Please switch the unit off after you finished a treatment session.

Page 12: User Manual - Saalmann medical

User manual Saalux® UV comb page 10

10 Therapy Recommendation

Removing dandruff:

Plaques and scales absorb

the UV radiation and prevent

the UV radiation from

penetrating into the diseased

skin layers. In case of

extensive infestations,

thoroughly remove plaques

and scales before starting

the UV therapy (e.g. with the

Saalux dandruff solution, see back page).

UV protection

Prior to starting the treatment, all healthy skin areas (the ears, amongst others)

should be covered or creamed with an according light protection screen in due

time (please consider application time!).

Prior to or during a therapy session, the skin must be free of topical applications

like, e.g. ointments; do not use sun protection on the skin that is to be treated.

Certain pharmaceuticals increase the skin‘s UV-sensitivity, a fact you might want

to discuss with your physician! Since scales on the scalp can impact treatment

success, a thorough cleaning prior to the treatment session is imperative.

Moreover, moist skin has a better UV-absorption which means that the treatment

of moist skin (possibly after washing) can accelerate the therapeutic success.

Moisty skin

Moisty skin is more receptive for UV radiation. Therefore the application on

moisty skin (e.g. after washing the scalp) may accelerate the therapy success.

Operation of Timer

At the onset of the treatment session, please make sure that the count-down

timer is functioning properly (e.g. battery o.k.?)

Prior to starting a treatment session, plug the device into a suitable outlet, put on

the protective goggles and keep the device switched on for approx. 5 min in order

to achieve a stable UV-output.

Page 13: User Manual - Saalmann medical

User manual Saalux® UV comb page 11

Please set the provided count-down timer by

pressing the according buttons „MIN“ for minutes

and „SEC“ for seconds to the desired treatment

time. Pressing the „Stop/Start“-button starts or

interrupts the countdown for treatment time. By

simultaneously pressing both „MIN“ and „SEC“

push buttons, the count-down timer resets to

„00:00“.

Page 14: User Manual - Saalmann medical

User manual Saalux® UV comb page 12

Finding the right dose and treatment duration:

It is common nowadays to use the classification made by the American

dermatologist Thomas Fitzpatrick in 1975 to define various skin types. Dark skin

types (type 5 and 6) are very rare at our latitude and thus are not taken into

account here.

The following applies:

Persons of skin type 1: (pale white skin; blond or red hair - always burns,

never tans) are not suitable for UV-therapy!

Skin type 2: fair; blond hair - usually burns, tans minimally (fair European type).

Skin type 3: fair, light-brown or brown hair, tans uniformly after repeated sun

exposure (dark European type T).

Skin type 4: brown or black hair - rarely burns, always tans well (Mediterranean

type)

The following dosage is recommended for patients of skin type 2, 3, and 4.

Please note that these doses refer to the treatment of the entire scalp and

never just to one spot which would result in an overdosage in the form of an

erythema (sun burn)! Special attention should be paid to the inner surfaces of the

outer ears. They should not be treated for an extended period since they are

extremely sensitive to UV light (light protection screen see above).

The treatment times indicated are mere guide values; please consult with your

dermatologist to determine your individual numbers. Upon reaching the highest

dosage indicated for the according skin type, it is not sensible to increase further

the dosage arrived at is to be maintained. Keep in mind, however, that excessive

doses can lead to an acute aggravation of your skin condition (the so-called

Köbner phenomenon) and too low doses result in an unnecessarily increased

„lifetime dose“ without the desired therapeutic success.

Page 15: User Manual - Saalmann medical

User manual Saalux® UV comb page 13

Dosage recommendations for Psoriasis with UV-B narrowband

Treatment duration for the entire scalp (for smaller surfaces, the treatment

time must be reduced accordingly):

Skin type II Session Time (min:sec) Dosage (mJ/cm2)

1 3:00 630

2 3:00 630

3 3:30 735

4 4:00 840

5 4:00 840

6 4:30 945

No further increase 5:00 1050

Skin type III Session Time (min:sec) Dosage (mJ//cm

1 3:30 735

2 3:30 735

3 4:00 840

4 4:30 945

5 4:30 945

6 5:00 1050

No further increase 6:00 1260

Skin type IV Session Time (min:sec) Dosage (mJ/cm2)

1 4:00 840

2 4:00 840

3 4:30 945

4 5:00 1050

5 5:00 1050

6 5:30 1155

No further increase 7:00 1470

Page 16: User Manual - Saalmann medical

User manual Saalux® UV comb page 14

Dosage recommendations for Vitiligo with UV-B narrowband

Treatment duration per body region:

Session Time (min:sec) Dosage (mJ/cm2)

1 0:20 70

2 0:40 140

3 1:00 210

4 1:20 280

5 1:50 385

6 2:20 490

7 2:50 595

8 3:20 700

9 3:50 910

10 4:20 1050

No further increase

Dosage recommendations for Neurodermatitis with UV-A1

Treatment duration per body region:

Session Time (min:sec) Dosage (J/cm2)

1 1:00 0.5

2 2:00 1.0

3 3:00 1.5

4 4:00 2.0

5 5:00 2.5

6 6:00 3.0

7 8:00 4.0

8 10:00 5.0

9 12:00 6.0

Page 17: User Manual - Saalmann medical

User manual Saalux® UV comb page 15

Conducting the Therapy

Only use the device in a dry environment. Always use the UV protective goggles

provided and never look into the UV lamp with unprotected eyes! While you

conduct the treatment, there should not be any additional persons close by

(exposure to scatter radiation).

Always protect your eyes with

the UV protective goggles!

According to skin type, start the therapy of the entire scalp with 3 (skin type 2),

3.5 (skin type 3) or 4 (skin type 4) minutes. Please position the count-down timer

where it is easily visible and acoustically perceivable for you; after counting down

to zero, an acoustic signal will sound for approx. 30 seconds. You can turn it off

by pressing any button. After pressing the Start/Stop button, the previously set or

lapsed time will appear in the display again.

The treatment is to take place slowly, distributed uniformly over the head and

against the direction of hair growth with parallel alignment of the radiation source

to the skin. The hair parter or comb attachment facilitates reaching the hairy scalp

skin and ensures the required treatment distance.

Page 18: User Manual - Saalmann medical

User manual Saalux® UV comb page 16

Other skin lesions (besides those on the scalp) are treated in an identical way but

always with mounted comb attachment.

The treatment should be conducted three to five times weekly. The duration of

the treatments depends on the severity of the skin disease. Generally, 20 - 25

sessions should be sufficient for the skin conditions to subside. A prolonged

maintenance treatment is not recommended.

Therapy monitoring:

Following every treatment session, monitor the treated skin areas for therapeutic

success as well as for possible side effects:

Should you discern side effects like a sun burn or painful change in the diseased

skin, you have to reduce the dose for the next treatment by 40% and you may

only continue with the treatment after the side effects have abated. If in doubt,

consult your attending physician.

Should you discern side effects like a sun burn or painful change in the healthy

skin, make sure to provide better protection for the next treatment like using

sunscreen with a high protection factor or more carefully cover these areas with

textiles..

Should you not experience any successful therapy outcome at all, gradually

increase the dose as described in the tables. If you have reached the maximum

dose according to your skin type and still do not notice any therapeutic effect, the

service life of the UV lamp may be expired (see chapter 14). If in doubt, consult

your attending physician.

After every individual treatment, document your

therapy outcome and success in the patient diary

provided and discuss your therapy results regularly

with your attending physician.

Page 19: User Manual - Saalmann medical

User manual Saalux® UV comb page 17

End of a treatment series:

To maintain the positive treatment outcome, it is recommended to „phase out“ the

therapy after the lesions have disappeared. This can be done by e.g. decreasing

daily treatment for the next 3 weeks to 3 times weekly, for 3 weeks to 2 times

weekly and for 3 weeks to once a week.

11 Cleaning and Disinfection

Prior to cleaning and disinfecting, switch off the device and pull the plug from the

outlet. Let the device cool off before you begin cleaning. You achieve better

cleaning results if you pull the comb attachment from the unit and clean it

separately.

Wipe the comb housing with a

moist cloth. If needed, the comb

attachment can be detached from

the housing and cleaned on the

inside and outside under running

water with a mild soap or dish

detergent. Avoid wiping either

device or comb attachment with a

dry cloth which can scratch the

surface.

Do not use aggressive or solvent-based cleaners. These affect the surfaces of

the device. Avoid any penetration of liquids during cleaning.

When using the device by several patients, the comb attachment must be

cleaned and disinfected before any patient change, in order to prevent infections

between patients. The following disinfectants can be used for this purpose:

• Descosept Spezial (wiping disinfection)

• Microzid sensitive liquid (wiping disinfection)

• Sani Cloth Active (wiping disinfection)

For a sufficient disinfecting effect, the application instructions of the respective

manufacturers must be observed. If other disinfectants are used, only products

suitable for acrylic glass are to be selected.

12 Transport and Storage

Protect the UV comb during transportation from undesirable shocks; the UV lamp

may be damaged (glass breakage). Store the therapy device in dry rooms and do

not expose it to high temperatures.

Page 20: User Manual - Saalmann medical

User manual Saalux® UV comb page 18

13 Errors and Troubleshooting

UV lamp does not light - Check the outlet or use another outlet. Verify that

the UV lamp is tightly inserted into the socket.

First switch off the device and unplug the power

cord.

If this did not fix the problem, contact the address specified in the manual.

14 Life cycle and service life

The service life of the UV comb is essentially dependent on the frequency of use.

The average service life of the UV lamp is 500 hours. After this runtime, UV-

radiation decreases. This also becomes evident by a decreasing therapy result. A

defective or poor UV lamp may only be replaced by the manufacturer or

professionals trained and authorized by the manufacturer. The use of a wrong UV

lamp can cause burns. After replacing the UV lamp, the treatment duration has to

be determined again (see chapter 10).

15 Maintenance and Repair

For commercial use the manufacturer recommends to carry out maintenance at

the latest every 2 years, which is generally also recommended for private use.

The commercial user is responsible for complying with all applicable national

regulations and inspections (e.g. occupational safety).

For maintenance or repair ship in the original packaging if possible. Please make

sure that the device is protected against shocks and that packaging is suitable for

the method of shipment selected.

Please don’t forget to clean the device and accessories prior to shipping it!

16 Warranty

The UV comb has been manufactured and tested with the greatest care. Should,

however, a malfunction occur, we grant you a manufacturer warranty for all

defects caused by material deficiency or manufacturing error. The manufacturer

warranty extends over 4 years for final customers/consumers and 2 years for

commercial customers (applicable are the provisions of the manufacturer‘s

general terms and conditions in the version in force at the date of purchase).

Any intervention on the therapy device by buyer or third parties renders the

warranty claim void. Any defects or errors which are or might be caused by

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User manual Saalux® UV comb page 19

improper handling or disregard for the „intended use“ or the user manual, result in

the immediate loss of warranty claims against the manufacturer.

Categorically excluded from all warranty claims are wear parts or glass breakage

(e.g. the UV lamp). Also excluded from the warranty is the UV-intensity of the UV

lamp.

Should you have any reason for a claim, please get in touch with us. The contact

information is specified in the user manual.

17 Electromagnetic compatibility

Medical-electrical devices are subject to special precautions regarding EMC.

Please refer to appendix 1 for information on specific requirements for the

electromagnetic environment.

18 Spectral Distribution of the Flow of Radiation

UV-B narrowband UV-A1 (370 nm max.)

(Source: Medical Treatment Phototherapy, Philips)

19 Technical Data

UV-Output UV-B narrowband (311 nm): approx. 3.5 mW/cm²

(comb attachment level) UV-A1 (370 nm max.): approx. 8 mW/cm²,

each for continuous operation and +/- 20%

Voltage/Frequency EU version - 230V/50 Hz

(see page 1) UK version - 240V/50Hz

JP1 version - 100V/50Hz

JP2 version - 100V/60Hz

US version - 120V/60Hz

Power input 40 VA

Page 22: User Manual - Saalmann medical

User manual Saalux® UV comb page 20

Weight handheld unit 165 g

Weight base unit 450 g

Protection class II double insulated

Device classification BF

Photobiological classification UV-B narrow band (311 nm): risk group 3 (according to EN 62471:2009) UV-A1 (370 nm max.): free group

Requirements for: Operation Transport and storage

Temperature

Relative humidity

Air pressure

+10°C to +30°C

30 % to 70 %

700 hPa – 1060 hPa

-20°C to +70°C

< 90 %, non-condensing

700 hPa – 1060 hPa

20 Disposal instructions

The device may not be disposed of as domestic

waste. Dispose of the device in a waste facility that

accepts electronics/electrical appliances.

21 Manufacturer contact information

If necessary, contact the manufacturer for assistance with regard to the use or

maintenance of the Saalux device or to report unexpected operations or

incidents.

Saalmann medical GmbH & Co. KG

Suedbahnstrasse 34

D-32547 Bad Oeynhausen

Germany

Internet www.saalmann-medical.de

Mail [email protected]

Phone +49 (0)5731 25450 0

Fax +49 (0)5731 25450 11

Page 23: User Manual - Saalmann medical

User manual Saalux® UV comb page 21

Appendix 1 – Electromagnetic compatibility

Electromagnetic emissions

The Saalux device is designed for operation in the electromagnetic environment specified below. The user should ensure that the device is used in such an environment.

interference emission Compliance Electromagnetic surrounding - Guidance

RF emission according CISPR 11

Group 1

The Saalux device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emission

according CISPR 11 Class B The Saalux device is suitable for use in all

establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Harmonic emission according IEC 61000-3-2

Not applicable

Voltage fluctuations/flicker emissions IEC 61000-3-3

Complies

Electromagnetic immunity

The Saalux device is designed for operation in the electromagnetic environment specified below. The user should ensure that the device is used in such an environment.

Immunity test IEC 60601- test level

Compliance level

Electromagnetic environment – guidance

Electrostatic discharge

(ESD) IEC 61000-4-2

± 8 kV contact discharge

max. ± 15 kV air discharge

± 8 kV

max. ± 15 kV

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical transients /

bursts

IEC 61000-4-4

± 2 kV for power supplies

± 2 kV

Mains power quality should be that of a typical commercial or hospital environment.

Surge

IEC 61000-4-5

± 1 kV for line(s) to line(s)

± 1 kV

Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, short

interruptions and voltage variations on power supply

input lines

IEC 61000-4-11

0 % UT for 0.5 cycle

0 % UT

for 1 cycle

70 % for 25 cycles

0 % UT

for 250/300 cycles

0 % UT for 0.5 cycle

0 % UT

for 1 cycle

70 % for 25 cycles

0 % UT

for 250/300 cycles

Mains power quality should be that of a typical commercial or hospital environment. If the user of the Saalux device requires continued operation during power mains interruptions, it is recommended that the Saalux device is powered from an uninterruptible power supply or a battery.

Power frequency (50/60 Hz)

magnetic field

30 A/m 30 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Page 24: User Manual - Saalmann medical

User manual Saalux® UV comb page 22

Electromagnetic Immunity

The Saalux device is designed for operation in the electromagnetic environment specified below. The user should ensure that the device is used in such an environment.

Immunity test IEC 60601- test level

Compliance level

Electromagnetic environment – guidance

Portable and mobile RF communications equipment should be used no closer to any part of the Saalux device, including cables, than the recommended separation distance (d in meter) calculated from the equation applicable to the frequency of the transmitter.

Conducted RF

IEC 61000-4-6

3 V rms

150 kHz to 80 MHz

6 V rms

150 kHz to 80 MHz within ISM bands and amateur radio bands

3 V rms

6 V rms

Radiated RF

IEC 61000-4-3

10 V/m

80 MHz to 2700 MHz

10 V/m

Radiated RF according IEC 61000-4-3

in close proximity to

wireless communication

devices

according to IEC 60601-1-2:2014 Table 9

passed (corresponds to a recommended safety distance of 0.3 m to the devices of the corresponding radio services)

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol

NOTE: These guidelines may not apply in all situations. Electromagnetic is affected by absorption and reflection from structures, objects and people.

IEC 61000-4-8

NOTE: UT is the a. c. mains voltage prior to application of the test level.

Page 25: User Manual - Saalmann medical

User manual Saalux® UV comb page 23

Appendix 2 – Patient diary

Name: ________________________________________

Physician: ______________________________

Date Treated area: Duration

(min)

Notes:

- therapeutic effect - side effects

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Date Treated area: Duration

(min)

Notes:

- therapeutic effect - side effects

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Date Treated area: Duration

(min)

Notes:

- therapeutic effect - side effects

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Date Treated area: Duration

(min)

Notes:

- therapeutic effect - side effects

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Date Treated area: Duration

(min)

Notes:

- therapeutic effect - side effects

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Date Treated area: Duration

(min)

Notes:

- therapeutic effect - side effects

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Accessories und add-on products for the Saalux® UV comb:

UV-protective goggles – large version

For professional staff and wearer of glasses

Art. No. 07-01-023-01

Saalux® dandruff solution

Gentle removal of dandruff before starting

the therapy:

- Faster therapy success

- Protection of healthy skin

- Clinically used recipe

- Vegetable base,

without salicylic acid

- Easy to wash out

75 ml bottle with handy soft tip applicator

and 200 ml refill bottle.

More information on: www.saalmann-medical.de

or order directly on: www.saalmann-medical-shop.de

Page 32: User Manual - Saalmann medical

User manual Saalux® UV comb page 30

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